MDMA-assisted therapy for posttraumatic stress disorder: A pooled analysis of ethnoracial differences in efficacy and safety from two Phase 2 open-label lead-in trials and a Phase 3 randomized, blinded placebo-controlled trial
Terence H. W. Ching, Monnica T. Williams, Julie B. Wang, Lisa Jerome, B. Yazar-Klosinski, A. Emerson, R. Doblin
Journal of Psychopharmacology June 21, 2022 DOI: 10.1177/02698811221104052 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Secondary analysis of pooled data from two Phase 2 open-label trials and a Phase 3 randomized, blinded placebo-controlled trial Peer reviewed |
|---|---|
| Sample size | 127 |
| Population | Adults with posttraumatic stress disorder (PTSD) from BIPOC and non-Hispanic White ethnoracial groups |
| Interventions | MDMA-assisted therapy placebo-assisted therapy |
| Topics | MDMA PTSD |
| Citations | 29 |
| Key findings | No significant ethnoracial difference in PTSD symptom reduction was observed among those receiving MDMA-assisted therapy, and among non-Hispanic Whites MDMA led to significantly greater symptom reduction than placebo. |
Abstract
Background: Limited ethnoracial diversity in previous ±3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) trials for posttraumatic stress disorder (PTSD) has prompted questions concerning whether Black, Indigenous, and People of Color (BIPOC) also benefit from this treatment.
Methods: Secondary analysis was conducted using a modified intent-to-treat sample pooled from two Phase 2 open-label trials and a Phase 3 randomized, blinded placebo-controlled trial to compare efficacy and safety of MDMA-AT for PTSD between BIPOC and non-Hispanic White participants. Four subgroups were of interest: MDMA-AT, BIPOC (n = 20); MDMA-AT, non-Hispanic White (n = 63); Placebo-assisted therapy (Placebo-AT), BIPOC (n = 17); and Placebo-AT, non-Hispanic White (n = 27). Planned comparisons tested subgroup differences in changes in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores from baseline to primary endpoint, controlling for study type and baseline scores. Adverse events (AEs) on the day of (day 0) to 2 days post-dosing were reported for each subgroup.
Results: In the MDMA-AT group, no significant ethnoracial difference in CAPS-5 change scores was observed. In the Placebo-AT group, BIPOC participants trended toward greater reductions in CAPS-5 scores than non-Hispanic Whites. Among non-Hispanic Whites, MDMA-AT was accompanied by significantly greater reductions in CAPS-5 scores than Placebo-AT. No treatment difference emerged among BIPOC participants. AEs were mostly rated as mild or moderate across subgroups.
Conclusions: These findings provide preliminary support for the efficacy and safety of MDMA-AT for treating PTSD across ethnoracial groups. There was also a trend toward greater efficacy with Placebo-AT among BIPOC participants. There was an imbalance in subgroups, highlighting the need for culturally responsive recruitment strategies to diversify future studies.
Comparable studies
Other randomized controlled trials on MDMA for PTSD, most cited first.